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Tuesday, October 15, 2024

FDA Approves Novocure’s Optune Lua® for Lung Cancer

 The first treatment of its kind for metastatic NSCLC, Optune Lua is approved for use concurrently with PD-1/PD-L1 inhibitors or docetaxel in adult patients with metastatic NSCLC who progressed on or after a platinum-based regimen

Results of the pivotal Phase 3 LUNAR trial represent the first substantial improvement in median overall survival in more than 8 years for this patient population

Optune Lua is a wearable treatment that delivers Tumor Treating Fields (TTFields), which exert physical forces on the electrically charged components of dividing cancer cells, resulting in cell death

https://www.businesswire.com/news/home/20241015381082/en/FDA-Approves-Novocure%E2%80%99s-Optune-Lua%C2%AE-for-the-Treatment-of-Metastatic-Non-Small-Cell-Lung-Cancer

FDA Clears Annovis to Launch Pivotal Phase 3 Alzheimer’s Studies

 Annovis Bio Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company developing transformative therapies for neurodegenerative disorders such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), announced today the successful outcome of the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on October 10, 2024. During the meeting, the FDA granted clearance to proceed with pivotal Phase 3 studies, based on the Company's Phase 2/3 clinical data showing symptomatic improvement in early AD patients. Annovis and the FDA have now aligned on a development path for buntanetap towards the filing of New Drug Applications (NDAs), one for short-term and one for long-term efficacy.

The Phase 3 program will investigate buntanetap in patients with early AD and will consist of two trials: a 6-month study aimed at confirming buntanetap’s symptomatic effects and an 18-month study designed to demonstrate potential disease-modifying effects. While the Company plans to run both studies, the completion of a well-designed and well-executed 6-month trial may be sufficient to support an NDA filing, potentially within one year of the study’s initiation.

https://www.globenewswire.com/news-release/2024/10/15/2963101/0/en/FDA-Clears-Annovis-to-Launch-Pivotal-Phase-3-Alzheimer-s-Studies-Paving-the-Way-to-NDAs.html

Jazz Combo May Delay Disease Progression, Extend Survival In Lung Cancer

 Jazz Pharmaceuticals plc (NASDAQ:JAZZ) revealed topline results from the Phase 3 clinical trial evaluating Zepzelca (lurbinectedin) in combination with the PD-L1 inhibitor Roche Holdings AG’s (OTC:RHHBY) atezolizumab (Tecentriq) compared to atezolizumab alone when administered as a maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC) following induction therapy with carboplatin, etoposide and atezolizumab.

The combination of Zepzelca and atezolizumab showed a statistically significant improvement in the primary endpoints of overall survival (OS) and progression-free survival (PFS), as assessed by an independent review facility (IRF), compared to treatment with atezolizumab alone.

“The results of the Phase 3 IMforte trial are highly encouraging and showed a statistically significant benefit for the Zepzelca and atezolizumab combination for extensive-stage small cell lung cancer patients receiving this treatment in the first-line maintenance setting,” said Rob Iannone, executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals.

Iannone added, “These results demonstrate the potential of this regimen to delay disease progression and extend survival for patients with this aggressive disease.”

The company plans to submit a supplement marketing application in the U.S. in the first half of 2025 to support this combination in the first-line maintenance setting.

The combination was generally well-tolerated. The preliminary safety data in the ongoing trial were consistent with the known safety profiles of Zepzelca and atezolizumab, with no new safety signals observed in the combination arm.


https://finance.yahoo.com/news/jazz-pharmaceuticals-zepzelca-tecentriq-combo-155046671.html

Pfizer taps Vanguard veteran for board amid fight with Starboard

 Pfizer appointed a former chief executive officer at Vanguard, the drug giant's biggest investor, to its board on Tuesday as it faces pressure from activist hedge fund Starboard Value.

Mortimer "Tim" Buckley served as Vanguard's chairman and chief executive until this year when he announced his retirement. Buckley is 55.

Vanguard, one of the world's biggest asset managers, is Pfizer's largest shareholder, owning nearly 9% of the company's stock, according to a regulatory filing.

Buckley's appointment was announced one day before Pfizer and Starboard Value are scheduled to meet, giving the hedge fund, which has built a $1 billion position, a chance to discuss the company's strategy and its stock price.

Starboard has not publicly detailed its concerns about Pfizer but people familiar with its thinking said the hedge fund is concerned about the stock price and spate of mergers and acquisitions. A spokesman for the hedge fund had no comment on the board news.

Pfizer, which has a market capitalization of $165 billion, said it began its search for a new board member in May. It named Buckley days after Starboard's campaign at the drugs giant became public.

Pfizer delivered the world's first Covid-19 vaccine but its stock price has lost nearly half of its value since 2021 when demand for the vaccine was high.

The standoff between the company and hedge fund took an unusual turn last week. Two former Pfizer executives had indicated they were working with Starboard to press for changes at Pfizer but then reversed course and said they supported the company's current CEO, Albert Bourla.

At Pfizer, Buckley will join the governance and sustainability committee and the audit committee.

Since Bourla became CEO in 2019, six new directors have been named to the board.

Buckley joined Vanguard 33 years ago as founder John Bogle's research assistant and held top roles before being named CEO in 2018. Salim Ramji took over as Vanguard CEO in July, the company said in a release.

https://money.usnews.com/investing/news/articles/2024-10-15/pfizer-taps-vanguard-veteran-for-board-amid-fight-with-starboard

GlaxoSmithKline sues Moderna for US patent infringement over COVID vaccines

 British drugmaker GlaxoSmithKline sued Moderna in U.S. federal court in Delaware on Tuesday, accusing its American rival of violating GSK's patent rights in messenger RNA (mRNA) technology with its blockbuster COVID-19 vaccine Spikevax.

According to the two lawsuits, Moderna's lipid nanoparticles for transporting fragile mRNA into the human body infringe several GSK patents covering similar innovations. GSK filed a related lawsuit against Pfizer and BioNTech in the same court in April over their COVID-19 vaccine. The new litigation seeks unspecified monetary damages.

A Moderna spokesperson said the company was aware of the new litigation and would defend itself against the claims. A GSK spokesperson said the drugmaker is "willing to license these patents on commercially reasonable terms and to ensure continued patient access."

The lawsuits add to a web of U.S. court cases involving Pfizer, BioNTech and Moderna over patent royalties for technology used in their vaccines, including one brought by Moderna against Pfizer in 2022.

Moderna earned $6.7 billion in revenue from Spikevax last year. Pfizer made $11.2 billion from sales of its and BioNTech's vaccine Comirnaty. Sales of both vaccines declined significantly last year from 2022.

GSK said in the new litigation that its patents cover mRNA technology pioneered in 2008 that provides "the foundation for Moderna's mRNA vaccine portfolio." GSK said it bought the rights to the inventions when it acquired part of Novartis' vaccine business in 2015.

https://money.usnews.com/investing/news/articles/2024-10-15/glaxosmithkline-sues-moderna-for-us-patent-infringement-over-covid-vaccines

Baxter bolsters IV supplies with imports to address US shortages in wake of Hurricane Helene

 Baxter International, which was forced by flooding from Hurricane Helene to temporarily halt production at its North Carolina facility, has started importing intravenous fluids from foreign facilities to help alleviate a U.S. shortage of essential medical supplies.

The FDA granted the Illinois-based company temporary permission last week to import the products from its facilities in Canada, China, Ireland and the U.K. Baxter requested additional import authorizations from the regulator for several other of its production sites, the company said in an Oct. 14 press release.

Baxter’s Marion, North Carolina, facility sustained water damage from flooding caused by heavy rains triggered by Helene. The facility produces 60% of the U.S. supply of IV solutions used on a daily basis across the country, according to the American Hospital Association.

The company activated seven plants that are part of its global network in a move to boost inventory, and two of the sites began shipping IV product to the U.S. last week.

“We have activated our global manufacturing network to help support patients and customers in the U.S.,” Baxter said in a Monday release. “We are ramping up production at these sites and will use air and other methods of transportation to get products to the U.S. as quickly as we are able.”

The cleanup at the Marion site continues, and the company brought back more than 1,000 employees last week to help with remediation efforts. The company reaffirmed its timeline to have the facility up and running in phases by the end of the year.

While Helene wrecked havoc, that storm was followed by Hurricane Milton, which cut a swath of destruction across central Florida last week. Milton forced B. Braun—another major IV solutions maker—to temporarily close its IV production facility in Daytona Beach, Florida. The facility sustained no damage and was reopened last Friday.

“The Daytona Beach facility is a key part of our plan to help address the shutdown of Baxter’s IV solutions manufacturing facility in North Carolina,” the company said in an update posted to its website. “In partnership with ASPR (Administration for Strategic Preparedness and Response), we are taking immediate steps to increase production of critical IV fluids at our plant in Irvine, California and will resume this plan at Daytona Beach.”

https://www.fiercepharma.com/manufacturing/baxter-bolsters-iv-supplies-imports-address-us-shortages-wake-hurricane-helene

Rickards: This Is What Will Destroy The Dollar

 by James Rickards via DailyReckoning.com,

Janet Yellen gave a speech on Sept. 26 at the 2024 U.S. Treasury Market Conference in New York. The speech was largely about risks in the banking system and the market for U.S. Treasury debt.

In a pre-speech interview with Politico, Yellen was asked about risks related to a smooth presidential transition in this election cycle. While that may seem like a straightforward question, it contained a particular bias that somehow Donald Trump, win or lose, might make the presidential transition difficult.

Difficulties could arise if Trump loses and claims the election was “rigged” or if Trump wins and radical groups like antifa commence violent protests. My estimate is that the former is unlikely, and the latter is far more likely but Trump haters in the media will take the opposite view.

Yellen replied, “It really is essential to our having a democratic system and a democratic government, and one of the tremendous strengths of our financial system is that it is based on strong institutions and the rule of law.”

While this statement may seem reasonable on its face, it was Yellen’s thinly disguised way of saying that Donald Trump’s actions on Jan. 6, 2021, and possible similar acts on Jan. 6, 2025, are a threat to the “rule of law” and therefore a danger to the stability of the financial system.

There are many forces at work in this statement by Yellen. In the first instance, this is an example of the Biden-Harris administration “all of government” approach.

What this means is that when the White House has a top priority (open borders, climate change, defeat Trump), every department and agency is expected to advance that goal even if the role of that agency has nothing to do with the issue at hand.

The White House says, in effect, “Find a way.”

So here is Yellen dragging the Treasury Department into the effort to discredit Trump by suggesting he is a threat to the financial system and the Treasury market. This political twist has almost nothing to do with the Treasury’s role in the executive branch except at a stretch.

The irony is that Yellen herself is the greatest threat to the Treasury market through her persistent and illegal efforts to steal $300 billion in U.S. Treasury securities owned by the Central Bank of Russia and held in custody in U.S. and European banks and the Euroclear clearinghouse in Brussels.

That particular threat to steal the Russian securities to be used as backing for a loan to Ukraine has accelerated efforts of the BRICS and the Global South to move toward a new currency linked to gold that would initially compete with the dollar in global payments and eventually rival the dollar as a major global reserve currency.

Those efforts will see major advances made at the BRICS leaders’ summit in Kazan, Russian Federation on Oct. 22–24 hosted by President Putin. The BRICS summit will announce new members. That’s important because expanding the membership is the key predicate to launching a viable payment currency.

Will a new BRICS currency instantly displace the dollar in its role as leading reserve currency? How much of a threat would it be? Read on...

BRICS Currency Won’t Displace Dollar Overnight

The original BRICs membership from 2009 consisted of Brazil, Russia, India and China. South Africa was added in 2010 when the group’s name was changed to BRICS. That group expanded significantly at the 2023 Leaders’ Summit in South Africa when Egypt, Ethiopia, Iran and the United Arab Emirates (UAE) were added.

(Argentina and Saudi Arabia were also permitted to enter but Argentina withdrew its application, and Saudi Arabia deferred its membership saying it was still considering the matter.)

The BRICS has been active over the years in institutionalizing its initiatives.

In 2014, the BRICS created the New Development Bank (NDB), which functions along the lines of the World Bank to promote infrastructure development in emerging economies. The NDB was capitalized with over $100 billion from its members and currently has 53 projects underway with commitments of over $15 billion to those projects.

In 2015, the BRICS established the Contingent Reserve Arrangement (CRA), which acts as a swing lender to members experiencing temporary balance of payments difficulties. In this regard, the CRA functions somewhat like the International Monetary Fund. Between the NDB and the CRA, it is clear that BRICS are intentionally constructing their own version of the Bretton Woods institutions but with their own controls and membership.

Beyond the nine current members, there’s a waiting list of over 20 aspiring members including economic powers such as Nigeria, Venezuela, Indonesia, Malaysia, Turkey, Thailand and Vietnam. Current members Russia, UAE and Iran make BRICS an oil output heavyweight.

Russia, China and South Africa are among the world’s largest gold producers. India and China alone have a combined population of 2.8 billion or 35% of the entire population of the globe.

The BRICS are part of an emerging Global South that is challenging the Collective West for world economic and geopolitical dominance.

The subject of a BRICS currency is confusing to most observers and is a fraught topic even for many experts. We’ll call the potential currency a BRIC for convenience although no formal name has been announced.

The starting point is to distinguish between a payment currency and a reserve currency. A payment currency is used to settle purchases and sales of tradable goods and services. A reserve currency is the denomination of the currency in which national savings are invested, typically in U.S. Treasury securities or gold.

Some currencies perform both functions as reserve and payment currencies especially U.S. dollars and euros. A finance minister or central banker can move from one to the other; currencies earned can be invested as reserves or reserves can be sold to finance purchases.

Still, it’s important to bear the distinction in mind when evaluating the use case for each currency, especially BRICs. Put differently, a flaw or deficiency in one usage does not preclude the other.

The BRICS currency is very far along in establishing itself as a viable payment currency. The prerequisites are: agreed-upon value (which can be fixed to another currency, floating or pegged to a weight of gold), secure payments channels (basically high-speed, encrypted digital pipes for authenticated message traffic), digital ledgers and an agreed issuer (the NDB based in Shanghai may be suitable for this purpose but another institution could be created).

The single most important element is a sufficiently large membership in the BRICS currency union such that a recipient of BRICS payments can use them for purchases in many jurisdictions for many goods and services.

This last point is where most alternative currency payments arrangements fall down. Russia can sell oil to China for yuan (which they are currently doing) but they are constrained in terms of where they can spend the yuan (basically limited to Chinese manufactured goods and semiconductors). The same issue arises when Russia sells oil to India (for rupees) or weapons to Iran (for rials). The seller is limited in terms of what they can buy with the trading partner’s currency.

This constraint goes away in a currency union with 15 or 20 members or more. If Russia earns BRICs from China, they can buy Embraer aircraft from Brazil or semiconductors from Malaysia. For that matter, use of a payment currency in a multimember currency union is not limited to members.

With access to the payment channels, non-members can nevertheless agree to receive the BRICS currency in payment confident in their ability to spend it among the other BRICS members who are trading partners. The proof of this is the eurozone, which is currently a 20-member currency union with a single central bank and worldwide acceptance of the euro.

Moving from a payment currency to a reserve currency is more difficult. The prerequisite here is a large, liquid bond market. That bond market has to be surrounded by extensive transactional and legal infrastructure including: securities at all maturities (30 days to 30 years), an underwriting system (primary dealers in the U.S.), an auction system for sales of new issues, a repo market to finance inventories, futures, options, other derivatives (swaps), settlement channels, custodians (DTCC, others), etc.

Above all, holders need a good rule of law regime on which to rely in the case of disputes or defaults. All of these elements exist in the reserve currency bond market nonpareil — the U.S. Treasury securities market. None of it exists in the form of a putative BRICS bond market. It would likely take 10 years or longer to create reserve currency infrastructure with the biggest single impediment being the rule of law.

That said, there are several interesting developments taking place.

The first is that the U.S. is squandering its rule of law advantage with sanctions on Russia, the freezing of the assets of the Central Bank of Russia and efforts to actually steal those assets and convert them into a $50 billion loan to Ukraine using structured finance.

Given this rogue behavior by the U.S., countries are becoming more cautious about large U.S. Treasury note reserves. This may account in part for the recent rally in the price of gold.

The second is the upcoming BRICS summit in Kazan.

Russia will announce significant progress in building out secure payments channels and will admit new members, which will drive the group closer to the critical mass needed to launch a currency union.

Finally, the impact of Yellen’s efforts to steal U.S. Treasury securities from Russia goes beyond the BRICS meeting and the rise of a new payment currency. Yellen’s blatant theft from the Central Bank of Russia is a driving force behind the price of gold reaching new all-time highs recently.

Central banks have been net buyers of gold since 2010, but the tempo of gold buying has increased as the U.S. rule of law under policymakers like Yellen begins to crumble.

Gold is a physical non-digital asset that cannot be stolen, frozen or seized provided it is in safe storage. Until the BRICS currency is ready, gold will be the asset of choice for foreign reserve managers faced with a rogue Treasury Secretary.

What began as a political hack (to beat Trump) has turned into another driver in the downfall of the dollar and the U.S. Treasury market. This is one more example of short-term, self-defeating thinking by the White House and the U.S. Treasury.

https://www.zerohedge.com/precious-metals/rickards-what-will-destroy-dollar